The Recall Desk
HighFDA (Devices)·Z-1507-2025·Announced 2025-04-23

[pending] BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 317435

Pending LLM rewrite. Source: FDA_DEVICE Z-1507-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

The recalled product

Product
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000
Manufacturer
Bard Access Systems, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025)
  • REGZ1439(11/30/2025)
  • REHP0860(11/30/2025)
  • REHQ3097(6/30/2026)
  • REHR0022(6/30/2026)
  • REHT1151(7/31/2026)
  • REHU1525(11/30/2026)
  • REHU2455(6/30/2026)
  • REHU2614(11/30/2026)
  • REHV2765 (7/31/2026)
  • REJN3472(2/28/2027)
  • REJP4216(5/31/2027)
  • REJQ2272(7/31/2027)
  • REJR1411(8/31/2027)
  • REJR2565(4/30/2027)
  • REJR2614(8/31/2027)
  • REJT0755(9/30/2027)
  • CK000540/00801741105142/REGZ1425(10/31/2025)
  • REHP0808(11/30/2025)
  • REHU1513(1/31/2026)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category